Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,049
- 主要终点
- Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
研究概览
简要总结
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.
详细描述
This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HIV infection
- •Patients that will be treated with Kaletra tablets independent from their participation in this study
排除标准
- •Hypersensitivity against Kaletra or other ingredients
- •Severe liver insufficiency
- •No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
- •Patients who received more than 1 protease inhibitor during their therapy history
结局指标
主要结局
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
时间窗: Baseline (Week 0) to Week 144
Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
时间窗: Baseline (Week 0) to Week 144
Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
次要结局
未报告次要终点